Background & Purpose

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PURPOSE

The purpose of this request for applications (RFA) is to facilitate translation of type 1 diabetes (T1D) research findings into viable immune therapeutic candidates. It is intended to support clinical studies that utilize novel approaches for testing single therapies or combinations that allow rapid evaluation of their potential for the treatment or prevention of T1D and late stage preclinical development of promising candidate therapies. It is JDRF’s hope that projects successfully completed under this RFA will attract partners for large scale trials towards regulatory approval of therapeutic candidates.

BACKGROUND

Type 1 diabetes (T1D) is a chronic autoimmune disorder in which auto-reactive T cells mediate the destruction of insulin-producing pancreatic β-cells, leading to lifelong dependence on exogenous insulin. To date, there are no approved immune therapies for the prevention or treatment of T1D. Immune therapies that have shown promising results in T1D have included therapies that enhance the number and/or function of regulatory T cells (Treg) as well as those that disable or ablate auto-reactive effector T cells (Teff). To maximize efficacy and patient impact in T1D, a variety of therapies that directly or indirectly result in the incapacitation of Teff and/or enhancement of Tregs will be essential. To this end, continued pre-clinical development of new immune targeted product candidates is needed.

There are inherent challenges in translating findings from preclinical models to human T1D, especially with respect to the dose, route, and frequency of administration to result in clinically meaningful outcomes. These challenges make it difficult to compare candidate therapies head to head. There is therefore a need for innovative strategies for early clinical testing of therapeutic candidates as well as pre-clinical testing strategies that will lend confidence to their potential for efficacy in humans. This RFA seeks proposals both from non-profit and for-profit institutions involving innovative immune targeted product candidates that require pre-clinical development, as well as, clinical projects designed to test therapeutic candidates (alone or in combination) in innovative clinical studies in T1D.